Control methods and devices for energy delivery

ABSTRACT

Control systems and methods for delivery of energy that may include control algorithms that prevent energy delivery if a fault is detected and may provide energy delivery to produce a substantially constant temperature at a delivery site. In some embodiments, the control systems and methods may be used to control the delivery of energy, such as radiofrequency energy, to body tissue, such as lung tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §119(e) of U.S.Provisional Application No. 60/674,106 filed Apr. 21, 2005, the contentsof which are incorporated herein by reference.

BACKGROUND

Various obstructive airway diseases have some reversible component.Examples include COPD and asthma. Asthma is a disease in whichbronchoconstriction excessive mucus production and inflammation andswelling of airways occur, causing widespread but variable airflowobstruction thereby making it difficult for the asthma sufferer tobreathe, Asthma is a chronic disorder, primarily characterized bypersistent airway inflammation. Asthma is further characterized by acuteepisodes of additional airway narrowing via contraction ofhyper-responsive airway smooth muscle.

In susceptible individuals, asthma symptoms include recurrent episodesof shortness of breath (dyspnea), wheezing, chest tightness and cough.Currently, asthma is managed by a combination of stimulus avoidance andpharmacology, Stimulus avoidance is accomplished via systemicidentification and minimization of contact with each type of stimuli. Itmay, however, be impractical and not always helpful to avoid allpotential stimuli.

Pharmacological management of asthma includes long term control throughthe use of anti-inflammatories and long-acting bronchiodilators. Shortterm pharmacological management of acute exacerbations may be achievedwith use of short-acting bronchiodilators. Both of these approachesrequire repeated and regular use of prescribed drugs. High doses ofcorticosteroid anti-inflammatory drugs can have serious side effectsthat require careful management. In addition, some patients areresistant to steroid treatment. The difficulty involved in patientcompliance with pharmacologic management and the difficulty of avoidingstimulus that trigger asthma are common barriers to successfulconventional asthma management. Accordingly, it would be desirable toprovide a management system and method that does not require regularpatient compliance.

Various energy delivering systems have been developed to intraluminallytreat anatomical structures by the controlled application of energy tointraluminal surfaces. Such systems may be specifically configured todeliver energy to lung tissue because of the clinical demands caused bythe heterogeneous nature of lung tissue, and specifically, variations inlung tissue lumen size due to the branching pattern of thetracheobronchial tree, variations in the vasculature of the lungs andvariations in the type of tissue in the lungs, including cartilage,airway smooth muscle, and mucus glands and ducts. Accordingly, a systemdesigned to delivery energy, and in some particular cases,radiofrequency energy, to lung tissue must take these variations intoaccount and deliver energy in a controlled manner.

Medical procedures involving the controlled delivery of therapeuticenergy to patient tissue are often demanding and may require a physicianto perform several tasks at the same time. In addition, medicalprocedures or other procedures may require specific energy deliveryparameters. As such, what has been needed is an energy delivery systemwith a user friendly control system that regulates and controls thedelivery of energy, prevents operation or energy delivery if a fault inthe energy delivery system is detected by the control system andprovides the user with information delivered in an easy to understandformat so that the information can be readily analyzed during ademanding medical procedure.

SUMMARY

In one embodiment, a system for delivering activation energy to atherapeutic energy delivery device having a temperature detectingelement and an energy emission element includes an energy generatorconfigured to be coupled to the energy emission element. The energygenerator has an activation state and a standby state, where activationenergy is delivered to the energy emission device in the activationstate and not in the standby state. A controller having a processor anda user interface surface with a visual indicator is coupled to theenergy generator and the processor is configured to activate the visualindicator when a temperature measured by the temperature detectingelement is not within a pre-determined temperature range.

In another embodiment, an energy delivery system includes a therapeuticenergy delivery device having a distal portion configured to bedelivered to a treatment site. The distal portion includes a temperaturedetecting element and an energy emission element. An energy generator isconfigured to be coupled to the energy emission element and has anactivation state and a standby state, where activation energy isdelivered to the energy emission element in the activation state and notin the standby state. A controller having a processor and a userinterface surface with a visual indicator is configured to activate thevisual indicator when a temperature measured by the temperaturedetecting element is not within a pre-determined temperature range.

In another embodiment, a system for delivering activation energy to atherapeutic energy delivery device having a temperature detectingelement and an energy emission element includes an energy generatorconfigured to be coupled to the energy emission element. The energygenerator has an activation state and a standby state, where activationenergy is delivered to the energy emission device in the activationstate and not in the standby state. A controller having a processor anda user interface surface with a visual indicator is configured toactivate the visual indicator when an impedance of an energy emissioncircuit between the energy generator, the energy emission element and apatient is not within a pre-determined impedance range.

In another embodiment, an energy delivery system includes a therapeuticenergy delivery device having a temperature detecting element and anenergy emission element. An energy generator is configured to be coupledto the energy emission element and has an activation state and a standbystate, where activation energy is delivered to the energy emissionelement in the activation state and not in the standby state. Acontroller having a processor and a user interface surface with a visualindicator is configured to activate the visual indicator when animpedance of an energy emission circuit between the energy generator,the energy emission element and a patient is not within a pre-determinedimpedance range.

In yet another embodiment, a system for delivering activation energy toa therapeutic energy delivery device having a temperature detectingelement and an energy emission element includes an energy generatorconfigured to be coupled to the energy emission element. The energygenerator has an activation state and a standby state, where activationenergy is delivered to the energy emission device in the activationstate and not in the standby state. A controller having a processor anda user interface surface with a first visual indicator and a secondvisual indicator, is configured to activate the first visual indicatorwhen a temperature measured by the temperature detecting element is notwithin a pre-determined temperature range and to activate the secondvisual indicator when an impedance of an energy emission circuit betweenthe energy generator, the energy emission element and a patient is notwithin a pre-determined impedance range.

In another embodiment, an energy delivery system includes a therapeuticenergy delivery device configured to be delivered to a treatment site.The energy delivery device has a temperature detecting element and anenergy emission element. An energy generator is configured to be coupledto the energy emission element and has an activation state and a standbystate, where activation energy is delivered to the energy emissionelement in the activation state and not in the standby state. Acontroller having a processor and a user interface surface with a firstvisual indicator and a second visual indicator is configured to activatethe first visual indicator when a temperature measured by thetemperature detecting element is not within a pre-determined temperaturerange and to activate the second visual indicator when an impedance ofan energy emission circuit between the energy generator, the energyemission element and a patient is not within a pre-determined impedancerange.

In another embodiment, an energy delivery system includes a therapeuticenergy delivery catheter having an electrode and temperature detectingelement disposed on a distal portion of the catheter. The distal portionof the catheter is configured to be delivered to a treatment siteadjacent target tissue of a patient and deliver a treatment cycle oftherapeutic RF energy to the target tissue. An RF energy generator isconfigured to be coupled to the electrode and has an activation stateand a standby state, where RF energy is delivered to and emitted fromthe electrode in the activation state and not in the standby state. Acontroller having a processor and a user interface surface with a firstvisual indicator and second visual indicator is configured to processtemperature measurements taken by the temperature detecting element andimpedance measurements between the RF energy generator and the targettissue prior to activation of the RF energy generator to the activationstate. The processor is also configured to activate the first visualindicator if a temperature measured by the temperature detecting elementis not within a pre-determined temperature range and activate the secondvisual indicator when an impedance between the RF energy generator andtarget tissue adjacent the electrode is above a predetermined value.

These features of embodiments will become more apparent from thefollowing detailed description when taken in conjunction with theaccompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a system for delivering energy to the walltissue of a patient's lung.

FIG. 2 is an enlarged view of a distal portion of a therapeutic energydelivery device.

FIG. 3 is an enlarged view of the encircled portion 3 in FIG. 2illustrating a more detailed view of an energy emission element andtemperature detecting element of the therapeutic energy delivery device.

FIG. 4 is an elevational view of a user interface surface of acontroller,

FIGS. 5A and 5B are flow diagrams depicting various processes androutines that control the user interface surface elements.

DETAILED DESCRIPTION

Embodiments of systems and methods for delivering energy to tissue of apatient in a controlled manner are discussed, and specifically, systemsand methods for controlled delivery of radiofrequency (RF) energy tolung tissue, bronchial tissue or both, Embodiments of the systems andmethods may be configured to consolidate and effectively communicaterelevant information to a user of the systems, including detectingaccessory connections (e.g. therapeutic device, footswitch, electrodereturn pad, or other) and serving as an automatic trouble shooting guidewith user friendly instructions, information, indicators and the like.

FIG. 1 shows a schematic diagram of a system for delivering therapeuticenergy 10 to tissue of a patient having an RF energy generator 12, acontroller 14 coupled to the energy generator, a user interface surface16 in communication with the controller 14 and a therapeutic energydelivery device, in the form of an RF energy delivery catheter 18,coupled to an interface coupler 20 on the user interface surface 16. Thecontroller 14, which is coupled to the energy generator 12 and userinterface surface 16, is configured to control the energy output of theenergy generator 12. The user interface surface 16 may include switches,a digital display, visual indicators, graphical representations ofcomponents of the system and an audio tone generator as well as otherfeatures. The controller 14 includes a processor 22 that is generallyconfigured to accept information from the system and system components,and process the information according to various algorithms to producecontrol signals for controlling the energy generator 12. The processor22 may also accept information from the system 10 and system components,process the information according to various algorithms and produceinformation signals that may be directed to the visual indicators,digital display or audio tone generator of the user interface in orderto inform the user of the system status, component status, procedurestatus or any other useful information that is being monitored by thesystem. The processor 22 of the controller 14 may be digital ICprocessor, analog processor or any other suitable logic or controlsystem that carries out the control algorithms. Some of the controlalerts, information, feedback and testing routines are shown in the flowdiagrams of FIGS. 5A and 5B.

The system 10 also includes an electrode return pad 24 and a footswitch26, both of which are coupled to respective interface couplers 28 and 30on the user interface surface 16. The user interface surface 16 alsoincludes a digital display 32 that may he used to display numeric datato a user of the system 10. The arrangement of the user interfacesurface 16 provides a user friendly interface for the system 10 thatprovides feedback and system information to a user in an intuitivedisplay format System components that couple to the user interfacesurface 16, such as the footswitch 26, electrode return conductive pad24 and energy delivery catheter 18, couple to the user interface surface16 adjacent graphical representations of the respective systemcomponents. In addition, visual indicators that are configured todisplay information about these various system components may also bedisposed adjacent or within the respective graphical representation ofeach system component. This configuration allows a user to easily andintuitively couple system components to the proper interface on the userinterface surface 16 and also allows a user to easily and intuitivelycorrelate audio and visual system feedback to the appropriate systemcomponent.

Referring again to FIG. 1, the energy delivery catheter 18 includes anelongate shaft 34, a handle 36 secured to a proximal end of the elongateshaft 34 and a control cable 38 that extends from the handle 36 to aproximal coupler 40 that is configured to couple to the interfacecoupler 20 on the user interface surface 16. A sliding actuator 42 onthe handle 36 controls the radial expansion and contraction of a distalelectrode basket 44 disposed on a distal end of the elongate shaft 34.The elongate shaft 34 may have a variety of configurations, includingstiff, flexible, steerable with distal tip deflection and the like. Theelongate shaft 34 and distal portion may also be configured and sized topermit passage of the elongate shaft 34 through the working lumen of acommercially available bronchoscope. In addition, the controller 14 mayalso include an optional interface coupler (not shown) that isconfigured to couple to a bronchoscope camera trigger such that when theprocessor 22 of the controller 14 initiates a treatment cycle byswitching the RF energy generator from a standby state to an activationstate, a triggering signal is also generated by the controller toinitiate video taping or displaying of an image produced by thebronchoscope camera which is coupled to a bronchoscope being used toposition the energy delivery catheter 18 during a procedure or treatmentcycle. Alternatively, an interface couple may provide the ability tosend some or all of the controller output or feedback to thebronchoscope video processor or monitor. This feature allows display ofinformation ordinarily on the controller's user interface surface todisplay on any of the bronchoscope video monitors. Additionally,additional controller output information that is not displayed on thecontroller's user interface surface can be displayed on any of thedisplays associated with the bronchoscope. This feature allow the thephysician to focus on the bronchoscope display monitor when performing aprocedure.

The distal electrode basket 44 may be seen in more detail in FIGS. 2 and3. The distal electrode basket 44 is a flexible and resilient ovalshaped basket that includes an energy emission element in the form of anelectrode 46 that is formed from an exposed section of a basket leg 48which is nominally coated with an electrical insulator material 50 inthe areas outside of the exposed section. The distal electrode basket 44also includes a temperature detection element in the form of athermocouple 52 disposed on or adjacent the electrode 46. Thethermocouple 52 has leads 54 and thermocouple termination points 56which are secured to the exposed section 58 of the basket leg orelectrode 46.

The leads 54 of the thermocouple 52 and a conductor (not shown) inelectrical communication with the electrode 46 extend proximally fromthe distal basket 44 to the handle 36 and then proximally through thecontrol cable 38 to the proximal coupler 40. This configuration allowsthe electrode 46 and the thermocouple leads 54 to be electricallycoupled in a modular arrangement with the controller 14 through the userinterface surface 16. The interface coupler 20 configured to accept theproximal coupler 40 of the energy delivery catheter 18 is disposedadjacent a graphical representation 60 of an embodiment of the energydelivery catheter 18 which, is printed on the user interface surface 16.This provides a useful visual prompt for a user who is setting up thesystem 10. Once the proximal coupler 40 is connected to the interfacecoupler 20 for the energy delivery catheter 18, the electrode 46 is nowin electrical communication with the RF energy generator 12, subject tocontrol and modulation by the controller 14 which may switch the RFgenerator 12 back and forth between an active state and a standby state,during which no RF can be delivered. In addition, the leads 54 of thethermocouple 52 are also in electrical communication with the controller14 so that the controller 14 may monitor the temperature of the tissueadjacent the electrode 46. In this arrangement, the RF energy generator12, controller 14 and user interface 16 form a system for controlleddelivery of activation energy to the energy delivery catheter 18,

The electrode 46 may be monopolar or bipolar, however, if the electrode46 is a monopolar electrode, a return electrode component 62 may be usedwith the system 10 in order to complete an electrical energy emission orpatient circuit between the RF energy generator 12 and a patient (notshown). The electrode return 62 includes the conductive pad 24, aproximal coupler 64 and a conductive cable 66 extending between and inelectrical communication with the conductive pad 24 and proximal coupler64. The conductive pad 24 may have a conductive adhesive surfaceconfigured to removably stick to the skin of a patient and with a largeenough surface area such that no burning or other injury to thepatient's skin will occur in the vicinity of the conductive pad 24 whilethe system 10 is in use The proximal coupler 64 is configured to coupleto the interface coupler 28 on the user interface surface 16. Theinterface coupler 28 for the electrode return 62 is disposed adjacent agraphical representation 68 of the electrode return 62 on the userinterface surface 16. Once again, this provides a useful visual promptfor a user who is setting up the system 10.

Once the proximal coupler 40 of the energy delivery catheter 18 and theproximal coupler 64 of the electrode return 62 have been coupled to thecontroller 14 via the respective interface couplers 20 and 28 of theuser interface surface 16, RF energy may be generated by the RFgenerator 12, i.e., the RF generator 12 is switched to an activationstate, and emitted from the electrode 46 of the distal basket 44 of theenergy delivery catheter 18 into target tissue of the patient adjacentthe electrode 46. The processor 22 may then adjust the output of the REgenerator 12 in order to maintain a substantially constant temperatureof tissue adjacent the electrode via a feedback loop between thethermocouple 52 and the processor 22. The processor 22 may use a controlalgorithm to process the temperature feedback and generate controlsignals for the RE generator 12. In addition, the control algorithm maybe configured to set predetermined dwell or activation times forembodiments of treatment cycles. Embodiments of control algorithms andsystem components that may be used in conjunction with control deviceand method embodiments discussed herein may be found in U.S. patentapplication Ser. No. 10/414,411, titled “Control System and Process forApplication of Energy to Airway Walls and Other Mediums”, filed Apr. 14,2003, which is incorporated by reference herein in its entirety.

Additionally, devices and methods for treating airway walls aredescribed in U.S. patent applications Ser. Nos.: 09/095,323 titledMETHOD AND APPARATUS FOR TREATING SMOOTH MUSCLES IN THE WALLS OF BODYCONDUITS filed Jun. 10, 1998; 10/414,253 titled MODIFICATION OF AIRWAYSBY APPLICATION OF ENERGY filed Apr. 14, 2003; 09/436,455 titled DEVICESFOR MODIFICATION OF AIRWAYS BY TRANSFER OF ENERGY filed Nov. 8, 1999;09/999,851 titled METHOD FOR TREATING AN ASTHMA ATTACK filed Oct. 25,2001; 10/810,276 titled METHOD OF TREATING AIRWAYS IN THE LUNG filedMar. 26, 2004; 10/640,967 titled METHODS OF TREATING ASTHMA filed Aug.13, 2003; 10/809,991 titled METHODS OF TREATING REVERSIBLE OBSTRUCTIVEPULMONARY DISEASE filed Mar. 26, 2004; and 10/954,895 titledINACTIVATION OF SMOOTH MUSCLE TISSUE filed Sep. 30, 2004; and U.S. Pat.Nos.6,411,852 titled CONTROL SYSTEM AND PROCESS FOR APPLICATION OFENERGY TO AIRWAY WALLS AND OTHER MEDIUMS; and 6,634,363 titled DEVICESFOR MODIFICATION OF AIRWAYS BY TRANSFER OF ENERGY. Each of which of theabove are incorporated by reference herein in their entirety

In one embodiment, the RF generator 12 generates RF energy at afrequency of about 400 kHz to about 500 kHz in with a wattage outputsufficient to maintain a target tissue temperature of about 60 degreesC. to about 80 degrees C., specifically, about 60 degrees C. to about 70degrees C. The duration of the activation state for an embodiment of asingle treatment cycle may be about 5 seconds to about 15 seconds,specifically, about 8 seconds to about 12 seconds. Alternatively, theduration of the activation state of the RF generator may also be set tonot more than the duration required to deliver about 150 Joules ofenergy to the target tissue, specifically, not more than the durationrequired to deliver about 125 Joules of RF energy to target tissue.

The initiation of the activation state of the RF generator 12 may becarried out by a variety of devices and methods, however, the embodimentof FIG. 1 includes a user operated activation switch in the form thefootswitch 26. A conductive cable 70 is coupled to and disposed betweenthe footswitch 26 and a proximal coupler 72 which is configured to beelectrically coupled to the respective interface coupler 30 disposed onthe user interface surface 16. The interface coupler 30 for the proximalcoupler 72 of the footswitch 26 is disposed adjacent a graphicalrepresentation 74 of the footswitch 26 on the user interface surface 16.The footswitch 26 may be used in some configurations to initiate anactivation state of the RF energy generator 12 if all components of thesystem 10 are functioning and connected properly. This can be defined asthe controller entering into the ready mode.

Referring now to FIG. 4, a more detailed view of an embodiment of theuser interface surface 16 is shown, The user interface surface 16 may bea substantially rectangular and flat surface as shown in FIG. 4, but mayalso have any other suitable shape, size or configuration. The userinterface surface 16 may, in some embodiments, be any part of an energydelivery system, or component thereof, that a user may access or see inorder to impart information or receive information therefrom. Thecontroller 14 may have an alternating current (AC) power on/off switchthat may be located anywhere on the controller 14, or alternatively, onthe user interface surface 16. However, for the embodiment shown in FIG.4, the user interface surface 16 does not include an AC power on/offswitch. The controller 14 or user interface surface 16 may include anaudio tone generator (not shown) which may be used in conjunction withthe various visual indicators of the system 10 to alert a user to thestatus of the various components of the system 10. In one embodiment,the audio tone generator includes a speaker (not shown) which may bemounted on any suitable surface of the controller 12 or the userinterface surface 16.

The user interface surface 16 has a visual indicator in the form of amulti-colored LED (light emitting diode) ready indicator light 76 in theupper left hand corner of the user interface surface 16. The readyindicator light 76 may be activated or lit with a first color, such as agreen color, when the RF energy generator 12 is ready for use in astandby state. The LED indicator 76, may be activated and lit with asecond color, such as an amber color, when the RF energy generator 12 isswitched on into an activation state at which time a brief audio tonemay also sound upon the transition of the RF generator 12 from thestandby or ready state to the activation state with RE energy beingdelivered to the energy emission element 46 of the energy deliverycatheter 18. Additionally, a separate LED indicator 92 may be activatedand lit with a second color, such as a blue color, during RF energydelivery. Typically, a user activates the RF energy generator 12 for atreatment cycle by depressing and releasing the footswitch 26. The colorof the ready indicator light 76 may be switched back to the first colorif, during an activation cycle, the footswitch 26 of the system 10 isdepressed and released again so as to produce a footswitch shutoffresponse from the processor 22 which switches the RE energy generator 12from the activation state to the standby state. The second color oramber color may also be displayed by the ready indicator light 76 whenthe system 10 is engaged in a power on self-test (POST) mode duringwhich time the audio tone generator may be delivering a constant singlepitch tone. in addition, the second amber color may also be displayed bythe ready indicator when a fault with the energy delivery catheter 18,such as a broken electrode 46 or broken thermocouple 52, is detected bythe controller 14. The activation of the second color indicating a faultwith the energy delivery catheter 18 may also be accompanied by anaudible first error tone from the audio tone generator. The readyindicator light 76 may flash the first color, green, when the system 10is conducting a cycling of the AC power to the controller 14 in order toreset the system 10 during which time the audible first error tone mayalso be produced. In essence, the ready indicator light 76 emits a firstcolor when the system 10 is ready to use and a second color or ambercolor if the system 10 has detected a fault in the system 10 and is notready to use.

Below the LED ready indicator 76 is the graphical representation 74 ofthe footswitch 26 which is printed on the user interface surface 16. Thegraphical representation 74 of the footswitch 26 is directly above andadjacent to the interface coupler 30 which is configured to accept theproximal coupler 72 of the footswitch 26 assembly. The graphicalrepresentation 74 of the footswitch 26 adjacent the interface coupler 30for the footswitch 26 provides an intuitive and user friendly prompt forthe user to locate the plug in point for the footswitch 26 while settingup the system 10.

To the right of the graphical representation 74 of the footswitch 26 isthe graphical representation 68 of the electrode return assembly 62which includes the conductive pad 24, conductive cable 66 and proximalcoupler 64 and which is printed on the user interface surface 16. Thegraphical representation 78 of the proximal coupler 64 of the electrodereturn assembly 62 is disposed directly above and adjacent to theinterface coupler 28 for the proximal coupler 64 of the electrode returnassembly 62. A visual indicator in the form of an amber colored LEDlight 80 is disposed within the graphical representation 82 of theconductive pad 24 of the electrode return assembly 62 and on the userinterface surface 16. The visual indicator 80 may be configured to belighted in a steady state when the system 10 is proceeding through thePOST which may also be accompanied by a single pitch audible tone fromthe audio tone generator. The visual indicator 80 may also be activatedand lighted when the controller 14 measures an impedance in the patientcircuit that is above a predetermined value after 3 or more attempts toactivate the RF energy generator to the activation state. A second errortone may accompany the activation of the visual indicator in thiscircumstance. For some embodiments, the predetermined impedance valuefor the patient circuit may be above about 1000 Ohms, specifically,above about 900 Ohms. Such a high impedance measurement in the patientcircuit indicates an open circuit and requires that the user check thepatient circuit and try the system 10 another time The patient circuitincludes the electrode 46 and conductive cable 38 of the energy deliverycatheter 18, the patient (not shown) with the conductive pad 24 andelectrode 46 in electrical communication with the patient's body, andthe electrode return assembly 62, The visual indicator 80 may also beactivated or lighted in a flashing mode when a fault requiring the userto cycle AC power has been initiated by the processor 22, during whichtime a first audible error tone may also be generated by the audio tonegenerator.

To the right of the graphical representation 68 of the electrode return62, the graphical representation 60 of the energy delivery catheter 18is printed on the user interface surface 16 including the handle 36, theelongate shaft 34 and the distal electrode basket 44. The interfacecoupler 20 configured to accept the proximal coupler 40 of the energydelivery catheter 18 is disposed adjacent and directly below a graphicalrepresentation 84 of the handle 36 of the energy delivery catheter 18. Afirst visual indicator in the form of an amber LED light 86 is disposedwithin the graphical representation 88 of the distal electrode basket 44on the user interface surface 16. A second visual indicator 90, having asecond color different from the first visual indicator, in the form of ared LED light 90 is disposed within the graphical representation 84 ofthe handle 36.

The first visual indicator 86 may be activated and lighted for someembodiments of the system 10 when the controller 14 measures animpedance in the patient circuit that is above a predetermined value.For some embodiments, the predetermined impedance value for the patientcircuit may be above about 1000 Ohms, specifically, above about 900Ohms. A first audible error tone may also be generated during such anactivation. The first visual indicator 86 may also be lighted oractivated when the measured impedance of the patient circuit is abovesuch a predetermined value during at least 3 or more attempts toactivate the RE energy generator 12 to the activation state. In thiscircumstance, a second audible error tone may also be generated inconjunction with the activation of the first visual indicator 86. Thefirst visual indicator 86 may also be lighted in a steady state when theprocessor 22 of the system 10 is proceeding through the POST which mayalso be accompanied by a single pitch audible tone from the audio tonegenerator. The visual indicator 86 may also be activated or lighted in aflashing mode when a fault requiring the user to cycle AC power has beeninitiated by the processor 22, during which time a first audible errortone may also be generated by the audio tone generator.

The second visual indicator 90 may be activated or lighted in a flashingor intermittent mode when a fault with the energy delivery catheter 18,such as a broken electrode 46 or broken thermocouple 52, is detected bythe controller 14. The activation of the second visual indicator 90suggesting a fault with the energy delivery catheter 18 may also beaccompanied by an audible first error tone from the audio tonegenerator. The second visual indicator 90 may also be lighted in asteady state when the processor 22 of the system 10 is proceedingthrough the POST which may also be accompanied by a single pitch audibletone from the audio tone generator. The second visual indicator 90 mayalso be activated or lighted in a flashing mode when a fault requiringthe user to cycle AC power has been initiated by the processor 22,during which time a first audible error tone may also be generated bythe audio tone generator.

Another visual indicator 92 in the form of a graphical representation ofa radiating electrode is disposed on the user interface surface 16. ThisRF energy indicator 92, which may be a third color or blue LED, isactivated or lighted in a flashing mode during the time when the RFenergy generator 12 is switched to the activation state and deliveringRE energy to the energy delivery catheter 18. The RE energy indicator 92may also be lighted in a steady state when the processor 22 of thesystem 10 is proceeding through the POST which may also be accompaniedby a single pitch audible tone from the audio tone generator. The REenergy indicator 92 may also be activated or lighted in a flashing modewhen a fault requiring the user to cycle AC power has been initiated bythe processor 22, during which time a first audible error tone may alsobe generated by the audio tone generator.

A digital display 94 is disposed on the user interface surface 16 belowthe RE energy indicator 92 and is configured to display numericalinformation. The digital display 94 may be controlled or otherwise resetby a switch 96 disposed directly below the digital display 94 on theuser interface surface 16. In a normal mode, the digital display 94 willdisplay the number of successful treatment cycles delivered by thesystem 10 performed by a user of the system 10. If the switch 96 isdepressed for less than about 2 seconds to about 4 seconds, the numberof unsuccessful or incomplete treatment cycles is displayed for a briefperiod, such as about 5 seconds. After this brief period, the digitaldisplay 94 reverts back to a display of the number of completedtreatment cycles. When the switch 96 is depressed and held for more thana brief period of about 2 seconds to about 4 seconds, the digitaldisplay 94 shows a “0” for a short period, such as about I second. Ifthe switch 96 is held depressed during this short 1 second period, thecount of the complete and incomplete treatment cycles is reset to 0. Ifthe switch 96 is released during this short 1 second period, the digitaldisplay 94 reverts back to a display of the completed or successfultreatment cycles without resetting the treatment cycle counter.

Referring to FIG. 5, a variety of system process embodiments are shownin flow diagram form. In use, the system 10 for delivery of therapeuticenergy is first supplied with power, such as AC power, which may becarried out by a switch (not shown) on the controller 14 or userinterface surface 16, as discussed above. Once AC power is supplied tothe controller 14, the processor 22 initiates the POST cycle, indicatedby box 100, which tests the integrity of the processor 22, thecontroller 14 and the system 10 generally. If the POST fails, the userinitiates a cycling of the AC power in order to reboot the controller14, and specifically, the processor 22 of the controller 14. hiaddition, once AC power has been supplied to the controller 14, theprocessor 22 continually runs a first background algorithm, indicated bythe decision point “irrecoverable error” 102. The irrecoverable errortest checks for hardware and processor errors such as CPU configuration,COP timeout, ROM CRC error, RAM, illegal CPU instruction, software,non-volatile memory, RF current measurement errors. If such an error isdetected, the user should initiate a cycling of the AC power, asindicated by box 111, in order to reboot the controller 14, andspecifically, the processor 22 of the controller 14. During the cyclingof the AC power, the user will be informed of the cycling status by aflashing of all visual indicators on the user interface surface 16 aswell as a flashing of the digital display 94 and the concurrentgeneration of an audible error tone.

If the POST is successful, the processor 22 will initiate a testalgorithm that determines whether all connections of system components,such as the energy delivery catheter 18, return electrode 62 andfootswitch 26 are all properly coupled to the respective interfacecouplers 20, 28 and 30 of the user interface surface 16, as indicated bydecision point 104, If an error is detected during this routine, theready indicator light 76 will remain in the second or amber color state,indicating that the RF energy generator 12 is not ready or in thestandby state. Once the system components such as the energy deliverycatheter 18, electrode return 62 and footswitch 26 are properly coupledto the user interface 16, the processor 22 will initiate an algorithmthat determines whether the temperature detection element, orthermocouple 52, of the energy delivery catheter 18 is properlyfunctioning as indicated by box 106.

During this test, the processor 22 measures the temperature indicated bythe thermocouple 52 and compares the result to a predeterminedtemperature range, that encompasses room temperature for someembodiments. For example, the predetermined temperature range for someembodiments may be about 15 degrees C. to about 35 degrees C,specifically, about 20 degrees C. to about 30 degrees C. If the measuredtemperature indicated by the thermocouple 52 does not fall within thepredetermined temperature range, the processor 22 indicates a brokenthermocouple 52 by initiating an error message to the user whichincludes switching the ready indicator light 76 to the second or ambercolor in addition to initiating a flashing mode activation of the redLED second visual indicator 90 in the handle 84 of the graphicalrepresentation 60 of the energy delivery catheter 18. An audible errortone may also accompany the error message generated by the visualindicators 76 and 90. These error messages inform the user that it maybe necessary to replace the energy delivery catheter 18 with a new one,

Once the thermocouple test has been successfully performed, theprocessor 22 will switch the ready indicator light 76 to the first coloror green color indicating that the system 10 is now ready to perform atreatment cycle in a patient, as indicated by box 108. At this point,the user may then position the distal electrode basket 44 of the energydelivery catheter 18 such that at least one emission element orelectrode 46 is disposed adjacent target tissue of the patient, such assmooth muscle of the patient's bronchial airways. Once the electrode 46is properly positioned, the user depresses the footswitch 26 to initiatea treatment cycle, as indicated by user action/input box 110. Upondepression of the footswitch 26, the processor 22 immediately measuresthe impedance of the patient circuit, and if the impedance is below apredetermined maximum or within a predetermined impedance range, theprocessor 22 switches the RF energy generator 12 from the ready orstandby state to the activation state wherein RF energy is beingdelivered to the target tissue of the patient for the initiation of atreatment cycle.

For some embodiments of a normal treatment cycle, as indicated by resultbox 112, the processor 22 and algorithms run by the processor 22 areconfigured to maintain the RF energy generator 12 in the activationstate for a dwell time of about 5 seconds to about 15 seconds,specifically, about 8 seconds to about 12 seconds. The duration of thetreatment cycle may also be constrained by the total energy delivered tothe target tissue during the cycle. For example, the processor 22 mayexecute an algorithm which terminates the treatment cycle when the totalenergy delivered to the target tissue is up to about 150 Joules,specifically, up to about 125 Joules. During the treatment cycle, theprocessor 22 controls the output of the RF energy generator 12 in orderto maintain a substantially constant temperature of the target tissue.The temperature of the target tissue during a treatment cycle embodimentmay be maintained at a temperature of about 60 degrees C. to about 80degrees C., specifically, from about 60 degrees C. to about 70 degreesC. As discussed above, the processor 22 is able to maintain thesubstantially constant temperature of the target tissue by monitoringthe temperature of the target tissue via the temperature measuringelement or thermocouple 52 and processing the temperature information ina feedback loop with lowers the RF energy generator 12 output if themeasured temperature is higher than desired and increasing the RF energygenerator output if the measured temperature is lower than desired.

During the treatment cycle, the processor 22 will switch the blue RFenergy visual indicator 92 to an activated solid or flashing mode andwill activate the audio signal generator to generate a dual pitchaudible tone from the audible tone generator that repeats a high pitchthen low pitch audible tone during the treatment cycle, followed by along single pitch tone at the end of a successful cycle. If an erroroccurs in the middle of a treatment cycle, an audible error tone will begenerated and the visual indicator or indicators indicative of the errorwill be activated as discussed above. As discussed above, a treatmentcycle may also be interrupted by the user's depression of the footswitch26 during the treatment cycle to initiate a footswitch shutoff, asindicated by user action box 114. This may be done if the user feelsthat the system 10 is operating improperly for any reason, the userfeels that the location of the electrode 46 is wrong, or for any otherreason. A footswitch shutoff action by the user returns the system 10 tothe RF generator ready state, indicated by box 108, but does not log acompleted or successful treatment cycle on the digital display 94. Ifthe treatment cycle is successfully completed, the digital display 94will display a count of “1”, indicating one successfully completedtreatment cycle.

If an error occurs during the treatment cycle, as indicated by resultbox 116, or the footswitch shutoff option is used, a “0” will remaindisplayed. However, if the display control switch 96 is depressed formore than about 2 seconds to about 4 seconds, the digital display 94will show a “1”, indicating one incomplete or unsuccessful treatmentcycle. The user may continue to deploy the energy delivery catheter 18to new locations within the patient's anatomy and activate the RF energygenerator 12 to the activation state for any desired number of treatmentcycles. If an error occurs during a treatment cycle, as indicated byresult box 116, the user interface 16 will then display via theappropriate visual indicators and audible tone indicators, the type oferror that has occurred and will recommend a course of action for theuser. After correction has been attempted by the user, the footswitch 26may again be depressed, as indicated by user action/input box 118, inorder to initiate another treatment cycle.

If the impedance of the patient circuit is greater than a predeterminedmaximum or not within a predetermined impedance range upon depression ofthe footswitch 26, as indicated by result box 120, one of two errormessages including visual indicators and audible tones may be generatedby the system 10. Specifically, if a high impedance is measured upon afirst depression of the footswitch 26 or a second depression of thefootswitch 26, as indicated by box 122, the error message “improvedeployment and continue” will be generated, as discussed above, wherebythe amber visual indicator 86 of the distal basket graphic 88 on theuser interface 16 will be activated and lighted and a first error tonewill be generated by the audible tone generator. In addition, anincomplete treatment cycle will be logged by the digital display 94.Once attempted correction has been made, the footswitch 26 may again bedepressed as indicated by user action/input box 124, in which case thetreatment cycle is reinitiated.

If on the third or subsequent depression of the footswitch 26 the sameerror is detected by the system 10, the “check patient circuit” errormessage will be generated, as discussed above, whereby the amber visualindicator 80 of the return electrode graphic 82 and the amber visualindicator 86 of the electrode basket graphic 88 on the user interfacesurface 16 will be activated and lighted. Such an error message may alsobe accompanied by a second audible error tone generated by the audibletone generator. In addition, an incomplete treatment cycle will belogged by the digital display 94, After attempted correction of theerror, the footswitch 26 may again be depressed, as indicated by useraction/input box 126, in order to initiate another treatment cycle.

With regard to the above detailed description, like reference numeralsused therein refer to like elements that may have the same or similardimensions, materials and configurations. While particular forms ofembodiments have been illustrated and described, it will be apparentthat various modifications can be made without departing from the spiritand scope of the embodiments of the invention. Accordingly, it is notintended that the invention be limited by the forgoing detaileddescription,

1-70. (canceled)
 71. A method for delivering energy to an airway in alung with a system having an energy generator, a temperature sensorcoupled to the system, a controller coupled to the energy generator, anenergy delivery element, and an indicator, the method comprising:sensing an ambient temperature with the temperature sensor coupled tothe system before inserting an electrode of the energy delivery elementinto a patient, wherein the controller is configured to cause theindicator to provide a first indication when the sensed ambienttemperature is not within a range; positioning the energy deliveryelement in the lung of the patient; initiating delivery of energy toairway tissue in the lung via the energy delivery element; sensing atemperature of the airway tissue with the temperature sensor coupled tothe system; and sensing impedance through airway tissue; wherein thecontroller causes the indicator to provide a second indication when theimpedance is above a predetermined impedance level.
 72. The method ofclaim 71, wherein the system further includes a system ready indicatorconfigured to emit a first color indicating a ready state and a secondcolor indicating a standby state, and the method further comprisesprecluding activation of the energy generator when the system readyindicator is emitting the second color.
 73. The method of claim 72,further comprising activating an audible signal generator simultaneouslywhen the system ready indicator changes from the first color to thesecond color.
 74. The method of claim 71, wherein the predeterminedimpedance is at least 900 Ohms.
 75. The method of claim 71, wherein therange is 15° C. to 30° C.
 76. The method of claim 71, further comprisingactivating an audible signal generator when the energy generator exits astandby state and enters an activation state.
 77. The method of claim76, wherein changing the energy generator from the standby state to theactivation state initiates a treatment cycle.
 78. The method of claim77, further comprising displaying a number of completed or uncompletedtreatment cycles on a user interface.
 79. The method of claim 71,wherein the system further includes a bronchoscope monitor or acontroller interface.
 80. The method of claim 71, wherein the indicatoris an energy delivery element indicator disposed on a user interface,the energy delivery element indicator being configured to represent atleast a portion of the energy delivery element, and wherein providing afirst indication includes emitting a first light and providing a secondindication includes emitting a second light.
 81. The method of claim 80,wherein the user interface includes a system ready indicator configuredto emit a first color indicating a ready state and a second colorindicating a standby state, and the energy delivery element indicatorcomprises a first component configured to emit the first light and asecond component configured to emit the second light separately andindependently from the first light, and the method further comprises:detecting whether the energy delivery element is electrically coupled tothe user interface, wherein the controller causes the system readyindicator to emit the first color when the energy delivery element iscoupled to the user interface and the second color when the energydelivery element is not coupled to the user interface.
 82. The method ofclaim 71, wherein the temperature sensor is mounted on the energydelivery element.
 83. The method of claim 71, wherein sensing impedancethrough airway tissue includes sensing impedance via the energy deliveryelement and a return electrode attached to the patient.
 84. The methodof claim 71, wherein the system is further configured to deliver energyin a bipolar configuration.
 85. The method of claim 71, whereinproviding the first indication indicates that the energy deliveryelement is not operable and should be replaced, and providing the secondindication indicates that the energy delivery element should beredeployed.
 86. A method for delivering energy to tissue of an airway ofa lung in a patient via an energy delivery device having an electrodeconfigured to contact tissue of the airway and a temperature sensorcoupled to the electrode, an energy generator coupled to the energydelivery device, a controller coupled to the energy generator, a userinterface, a first indicator, and a second indicator, wherein the firstindicator is configured to provide a first indication when the system isin a ready state and a second indication when the system is in a standbystate, the method comprising: detecting whether the energy deliverydevice is electrically coupled to the user interface, wherein thecontroller is configured to cause the first indicator to provide thesecond indication indicating the standby state if the energy deliverydevice is not coupled to the user interface; sensing an ambienttemperature via the temperature sensor coupled to the electrode beforeinserting the energy delivery device into a patient, wherein thecontroller is configured to cause the second indicator to provide athird indication when a sensed value of the ambient temperature is notwithin a predetermined range; activating the first indicator to providethe first indication after performing the detecting and sensingprocedures when the energy delivery device is coupled to the userinterface and the sensed ambient temperature is within the predeterminedrange; positioning the electrode of the energy delivery device into thepatient in contact with the tissue of the airway; initiating delivery ofenergy to tissue of the airway; and sensing a temperature associatedwith tissue of the airway via the temperature sensor coupled to theelectrode, wherein the controller is configured to activate the secondindicator if the sensed temperature in the airway of the lung is notwithin the predetermined range.
 87. The method of claim 86, wherein thesecond indicator has a graphical representation configured to representat least a portion of the energy delivery device, providing the firstindication includes emitting a first color, providing the secondindication includes emitting a second color, and providing the thirdindication includes emitting light.
 88. The method of claim 87, furthercomprising precluding activation of the energy generator when the firstindicator is emitting the second color indicating the standby state. 89.A method for delivering energy to tissue in a patient via an energydelivery device having an electrode configured to contact the tissue anda temperature sensor coupled to the electrode, an energy generatorcoupled to the energy delivery device, a controller coupled to theenergy generator, and a user interface having a system ready indicatorand an energy delivery device indicator, wherein the system readyindicator is configured to emit a first color when the system is in aready state and a second color when the system is in a standby state,and wherein the energy delivery device indicator has a graphicalrepresentation configured to represent at least a portion of the energydelivery device including a first component configured to emit a firstlight and a second component configured to emit a second lightseparately from the first light, the method comprising: detectingwhether the energy delivery device is electrically coupled to the userinterface, wherein the controller is configured to cause the systemready indicator to emit the second color indicating the standby state ifthe energy delivery device is not coupled to the user interface; sensingan ambient temperature via the temperature sensor coupled to theelectrode before inserting the energy delivery device into a patient;positioning the electrode of the energy delivery device into thepatient; activating a switch that initiates delivery of energy to tissueof the airway; wherein the controller is configured to cause the firstcomponent of the energy delivery device indicator to emit the firstlight when the sensed temperature provided by the temperature sensorcoupled to the electrode is not within a predetermined temperature rangeindicating that the temperature sensor is not operable and the energydelivery device should be replaced; and wherein the controller isconfigured to cause the second component of the energy delivery deviceindicator to emit the second light when the sensed impedance is greaterthan a predetermined impedance level indicating that the electrodeshould be redeployed.
 90. The method of claim 89, wherein thepredetermined temperature range is from 15° C. to 30° C. and thepredetermined impedance level is at least 900 Ohms.